NCT04917445

Brief Summary

The purpose of this study is to determine if the utilization of the SPIKES protocol for delivering bad news is perceived to be more compassionate and effective than the current standard of care for IVF patients receiving negative pregnancy test results.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

June 17, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

May 26, 2021

Last Update Submit

May 24, 2022

Conditions

Infertility

Keywords

infertilityIVFSpikes protocol

Outcome Measures

Primary Outcomes (3)

  • Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion

    We revised the Communicating Bad News questionnaire which follows the SPIKES protocol, published by Gonzales-Cabrera et al. Their questionnaire had 25 items, Internal consistency was 0.816. The content validity was established via the Kaiser-Meyer-Olkin test (KMO) with a score of 0.683 and the Bartlett test of sphericity was p\<0.001. The principal component analysis supported a four dimension construct. There are 22 items rated 1, 2, 3 with a scoring range of 22-66. For the Compassion Assessment, there are 19 slots for the 5 categories so the scoring range is 5-95. The content validity was established via the Kaiser-Meyer-Olkin test (KMO) with a score of 0.683. and the Bartlett test of sphericity was p\<0.001. The principal component analysis supported a four dimension construct. There are 22 items rated 1,2,3 so the scoring range is 22-66. For the Compassion Assessment, there are 19 slots for the 5 categories so the scoring range is 5-95.

    Within 48 hours of phone call

  • Assess patient distress after receiving the negative pregnancy test phone call

    We will use 5-point Likert scales to assess patient distress after receiving the negative pregnancy test phone call. The Likert scale range is 1-5.

    Within 48 hours of phone call

  • Assess patient depression after receiving the negative pregnancy test phone call

    We will use 5-point Likert scales to assess patient depression after receiving the negative pregnancy test phone call. The Likert scale range is 1-5.

    Within 48 hours of phone call

Study Arms (2)

SPIKES Protocol Compassionate Call

EXPERIMENTAL

Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script.

Behavioral: Spikes-focused bad news protocol

Control: Standard of Care Call

NO INTERVENTION

Nurses who will continue to deliver bad news as they have been in the past without a script.

Interventions

Spikes-focused bad news protocolBEHAVIORAL

Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.

SPIKES Protocol Compassionate Call

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age \>18
  • Underwent an embryo or blastocyst transfer using their own eggs at participating clinic
  • Able to read and understand English
  • Access to email
  • Received a negative pregnancy test result phone call from a nurse involved in the research study

You may not qualify if:

  • Partners of patients undergoing treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Weill Cornell Medical Center Division of Reproductive Medicine

New York, New York, 10065, United States

Location

Related Publications (1)

  • Domar AD, Korkidakis A, Bortoletto P, Gulrajani N, Khodakhah D, Rooney KL, Gompers A, Hacker MR, Grill E. The impact of an adapted SPIKES protocol vs routine care in the delivery of bad news to IVF patients: an exploratory pilot multicenter randomized controlled trial. J Assist Reprod Genet. 2024 Sep;41(9):2367-2377. doi: 10.1007/s10815-024-03198-3. Epub 2024 Jul 19.

    PMID: 39026124DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Alice Domar, PhD

    Boston IVF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director of Domar Center for Mind Body Health

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 8, 2021

Study Start

June 17, 2021

Primary Completion

March 31, 2022

Study Completion

May 24, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

US(2)